Site Activation Specialist, FSP, home-based, sponsor dedicated, Austria

at  Syneos Health

ADDITIONAL INFORMATION:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees

• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.
• Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees Clinical Trial Assistants as applicable.
• Coordinates and liaises with Project Management and Clinical Monitoring to ensure country deliverables are obtained for submissions and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
• Oversight and coordination of local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical systems.
• Has ownership, oversight and impact on local regulatory compliance. The position has a significant impact on how a country can deliver country‐specific trial commitments and objectives especially during study start‐up.
• Works closely with the other departments to assess, prioritize and drive execution of specific clinical trials in order to support and manage the pipeline and local business needs to agreed timelines and budgets. Required to in/directly influence investigators, external partners and country operations to adhere to budget targets and agreed payment timelines.
• Works in partnership internally with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related‐interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value